title: Approval and withdrawal of new antibiotics and other antiinfectives in the U.S., 1980-2009.
abstract: Numerous reports have noted decreasing numbers of antibiotic approvals. To determine the context for this decline, we examined all new molecule entities (NMEs) and new biologic licenses (NBLs) approved by the FDA from 1980-2009, and compared approval rates of the 61 approved antibiotics to trends in other drug classes. We also tracked withdrawals of approved drugs and found more withdrawals for antibiotics than other drug classes. After adjusting for drugs subsequently withdrawn, the record for antibiotic innovation is less dire than previously reported. We also report problems with the quality of the approved antibiotics studied. Future policies providing incentives for new antibiotic development should not be based on simple numerical targets and key provisions should ensure appropriate quality as well as quantity of antibiotic drug innovation.
authors.affiliation: Professor of Law at Boston University. Associate Clinical Professor of Medicine, George Washington University School of Medicine. Washington, DC. Associate Professor in the Division of Pharmaceutical Sciences, and Director of the International Center for Pharmaceutical Economics and Policy at the Massachusetts College of Pharmacy and Health Sciences, Boston, MA. Associate Professor in the School of Public Health and Health Sciences at the University of Massachusetts, Amherst. Assistant Professor of Medicine in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women's Hospital and Harvard Medical School.
authors.forename: Kevin
authors.initials: K
authors.lastname: Outterson
authors.forename: John H
authors.initials: JH
authors.lastname: Powers
authors.forename: Enrique
authors.initials: E
authors.lastname: Seoane-Vazquez
authors.forename: Rosa
authors.initials: R
authors.lastname: Rodriguez-Monguio
authors.forename: Aaron S
authors.initials: AS
authors.lastname: Kesselheim
mesh_terms: D000890:Anti-Infective Agents / Q000009:adverse effects; D017277:Drug Approval / Q000706:statistics & numerical data*; D006801:Humans; D056737:Safety-Based Drug Withdrawals / Q000706:statistics & numerical data*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000890:Anti-Infective Agents